A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease

NCT03033498 | Completed Phase 1 FDA Drug

• 1 other identifier: M15-738
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by a continuous subcutaneous infusion in subjects with Parkinson's disease.

Conditions

Parkinson's Disease (PD)

Outcome Measures

Primary Outcomes (6)

• Maximum Observed Plasma Concentration (Cmax) of Levodopa

  Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

  Hour 0-24

• Time to maximum observed plasma concentration (Tmax) of Levodopa

  Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.

  Hour 0-24

• Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa

  Area under the plasma concentration-time curve following a single infusion of ABBV-951.

  Hour 0-24

• Adverse Events

  Number of participants reporting adverse events

  24 hours

• Terminal phase elimination rate constant (β)

  Apparent terminal phase elimination rate constant (β or Beta)

  Up to 72 hours

• Terminal phase elimination half-life (T1/2)

  Terminal phase elimination half-life (t1/2) will be assessed.

  Up to 72 hours

Secondary Outcomes (1)

• Corrected QT (QTc) Interval

  Up to 76 hours

Study Arms (8)

ABBV-951 Dose 1

EXPERIMENTAL

Participants will receive dose 1 of ABBV-951.

Drug: ABBV-951

ABBV-951 Dose 2

EXPERIMENTAL

Participants will receive dose 2 of ABBV-951.

Drug: ABBV-951

ABBV-951 Dose 3

EXPERIMENTAL

Participants will receive dose 3 of ABBV-951.

Drug: ABBV-951

ABBV-951 Dose 4

EXPERIMENTAL

Participants will receive dose 4 of ABBV-951.

Drug: ABBV-951

ABBV-951 Dose 5

EXPERIMENTAL

Participants will receive dose 5 of ABBV-951.

Drug: ABBV-951

ABBV-951 Dose 6

EXPERIMENTAL

Participants will receive dose 6 of ABBV-951.

Drug: ABBV-951

ABBV-951 Dose 7

EXPERIMENTAL

Participants will receive dose 7 of ABBV-951.

Drug: ABBV-951

ABBV-951 Dose 8

EXPERIMENTAL

Participants will receive dose 8 of ABBV-951.

Drug: ABBV-951

Interventions

ABBV-951 DRUG

ABBV-951 administered by subcutaneous infusion.

ABBV-951 Dose 1; ABBV-951 Dose 2; ABBV-951 Dose 3; ABBV-951 Dose 4; ABBV-951 Dose 5; ABBV-951 Dose 6; ABBV-951 Dose 7; ABBV-951 Dose 8

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has a diagnosis of definite idiopathic PD, which is LD responsive, according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
• Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before dosing in this study. This regimen must include oral carbidopa/levodopa (CD/LD) tablets (e.g., Sinemet).
• Females must have negative results for pregnancy tests at screening and prior to confinement.
• If male, subject must be surgically sterile or practicing an adequate method of birth control from initial study drug administration until 30 days after last dose of study drug.
• Body Mass Index (BMI) is 18.0 to 38.0, inclusive.
• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).

You may not qualify if:

• Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
• History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
• Use of any medication from the prohibited concomitant therapies.
• Subjects with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m2 as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
• Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to initial study drug administration.
• Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (7)

Glendale Adventist Medical Ctr /ID# 166512

Glendale, California, 91206, United States

Location

Bioclinica Research - Orlando /ID# 169687

Orlando, Florida, 32806, United States

Location

Acpru /Id# 154976

Grayslake, Illinois, 60030, United States

Location

University of Kentucky Chandler Medical Center /ID# 169086

Lexington, Kentucky, 40536, United States

Location

Parexel Baltimore /ID# 169255

Baltimore, Maryland, 21225, United States

Location

QUEST Research Institute /ID# 166035

Farmington Hills, Michigan, 48334-2977, United States

Location

Carolina Phase I, LLC /ID# 166034

Raleigh, North Carolina, 27612, United States

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• AbbVie Inc.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2017
• First Posted: January 26, 2017
• Study Start: May 17, 2017
• Primary Completion: June 8, 2019
• Study Completion: June 8, 2019
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)